Back to resultsEfficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Primary wound closure
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Site Infection focused on measuring complicated appendicitis, wound closure, infection
Eligibility Criteria
Inclusion criteria
- Adult patients age 18 years or older
Have been diagnosed as gangrenous or ruptured appendicitis base on clinical criteria with the following conditions
a.Gangrenous appendicitis i.Erythematous or swelling of appendix and ii.Appearance of necrotic wall (dark, grayish color) b.Ruptured appendicitis i. Erythematous or swelling of appendix and ii.Appearance of hole in an appendix or iii.Rupture of appendix during a procedure c.Appearance of frank pus
Non-immunocompromised hosts which include
- AIDS
- History of end-stage renal disease (ESRD)
- History of autoimmune disease (SLE)
- Taking immunosuppressive agents (e.g, steroids, Cyclophosphamide, Tacrolimus, Mycophenolate mofetil)
- Cirrhosis with ascites
- Morbid obesity (BMI > 40 kg/m2)
- Non-pregnant women
- Willing to participate and provide written informed consent
Sites / Locations
- Vachira hospital
- Department of Surgery, Ramathibodi Hospital
- Chonburi hospital
- Pathumtani hospital
- Thammasat hospital
- Surin hospital
- Lampang hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Primary wound closure
Delayed primary wound closure
Arm Description
A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge.
A wound will be left open with saline-soaked gauze packing after the operative procedure and will be sutured around day 3 to 7 after operation
Outcomes
Primary Outcome Measures
Superficial surgical site infection (SSI)
Superficial SSI, which will be diagnosed using the Center for Disease Control (CDC) criteria as follows:
Infection within 30 days and
Involves only skin and subcutaneous tissue of the incision and
One of the following:
Purulent drainage,
organism isolated from culture of fluid or tissue
one of the following signs or symptoms:
pain or tenderness;
localized, swelling, redness, or
heat And the superficial incision is deliberately opened by surgeon
Secondary Outcome Measures
postoperative pain
• Postoperative pain will be assessed using visual analog scale (VAS, ranged from 0-10) at day 1 and 3
Quality of life
Quality of life will be assessed using the Thai EQ5D questionnaires before an operation, days 3 and 1 month after operation
Cost of treatment
Both direct and indirect costs of treatment will be recorded
Full Information
NCT ID
NCT01659983
First Posted
June 25, 2012
Last Updated
April 5, 2016
Sponsor
Ramathibodi Hospital
Collaborators
Thammasat Hospital, Chonburi Hospital, Vachira hospital, Pathumtani Hospital, Lampang Hospital, Surin Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01659983
Brief Title
Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis
Official Title
Comparison of Surgical Site Infection Between Delayed Primary Closure Versus Primary Closure in Complicated Appendicitis: A Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ramathibodi Hospital
Collaborators
Thammasat Hospital, Chonburi Hospital, Vachira hospital, Pathumtani Hospital, Lampang Hospital, Surin Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Research hypothesis:
Does delayed primary wound closure after appendectomy in adults with complicated appendicitis reduce postoperative superficial surgical site infection compare to primary wound closure.
Study design:
This study is a multicenter randomized controlled trial of delay versus primary wound closure in complicated appendicitis.
Setting:
Thammasat Hospital, Ramathibodi Hospital, Chonburi Hospital, Chonpratarn Hospital, Vachira Hospital, and Pathumthani Hospital
Participants:
Adult patients age 18 years or older and non-pregnant in women who have been diagnosed as gangrenous or ruptured appendicitis.
Outcome:
Superficial surgical site infection
Period of study:
August 2012 - August 2014
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
complicated appendicitis, wound closure, infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary wound closure
Arm Type
Experimental
Arm Description
A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge.
Arm Title
Delayed primary wound closure
Arm Type
Active Comparator
Arm Description
A wound will be left open with saline-soaked gauze packing after the operative procedure and will be sutured around day 3 to 7 after operation
Intervention Type
Procedure
Intervention Name(s)
Primary wound closure
Intervention Description
A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge.
Primary Outcome Measure Information:
Title
Superficial surgical site infection (SSI)
Description
Superficial SSI, which will be diagnosed using the Center for Disease Control (CDC) criteria as follows:
Infection within 30 days and
Involves only skin and subcutaneous tissue of the incision and
One of the following:
Purulent drainage,
organism isolated from culture of fluid or tissue
one of the following signs or symptoms:
pain or tenderness;
localized, swelling, redness, or
heat And the superficial incision is deliberately opened by surgeon
Time Frame
within 1 month after operation
Secondary Outcome Measure Information:
Title
postoperative pain
Description
• Postoperative pain will be assessed using visual analog scale (VAS, ranged from 0-10) at day 1 and 3
Time Frame
within 3 days after operation
Title
Quality of life
Description
Quality of life will be assessed using the Thai EQ5D questionnaires before an operation, days 3 and 1 month after operation
Time Frame
1 month after operation
Title
Cost of treatment
Description
Both direct and indirect costs of treatment will be recorded
Time Frame
1 month after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Adult patients age 18 years or older
Have been diagnosed as gangrenous or ruptured appendicitis base on clinical criteria with the following conditions
a.Gangrenous appendicitis i.Erythematous or swelling of appendix and ii.Appearance of necrotic wall (dark, grayish color) b.Ruptured appendicitis i. Erythematous or swelling of appendix and ii.Appearance of hole in an appendix or iii.Rupture of appendix during a procedure c.Appearance of frank pus
Non-immunocompromised hosts which include
AIDS
History of end-stage renal disease (ESRD)
History of autoimmune disease (SLE)
Taking immunosuppressive agents (e.g, steroids, Cyclophosphamide, Tacrolimus, Mycophenolate mofetil)
Cirrhosis with ascites
Morbid obesity (BMI > 40 kg/m2)
Non-pregnant women
Willing to participate and provide written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boonying Siribumrungwong, MD
Organizational Affiliation
Ramathibodi Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ammarin Thakkinstian, PhD
Organizational Affiliation
Ramathibodi Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patarawan Woratanarat
Organizational Affiliation
Ramathibodi Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Borwornsom Leerapan
Organizational Affiliation
Ramathibodi Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jittunut Hawanon
Organizational Affiliation
Thammasat Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Vachira hospital
City
Dusit
State/Province
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Facility Name
Department of Surgery, Ramathibodi Hospital
City
Rachatevi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Chonburi hospital
City
Meaung
State/Province
Chonburi
ZIP/Postal Code
20000
Country
Thailand
Facility Name
Pathumtani hospital
City
Meung
State/Province
Pathumtani
ZIP/Postal Code
12110
Country
Thailand
Facility Name
Thammasat hospital
City
Rang sit
State/Province
Patumtani
ZIP/Postal Code
12120
Country
Thailand
Facility Name
Surin hospital
City
Meung
State/Province
Surin
Country
Thailand
Facility Name
Lampang hospital
City
Meung
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
29946346
Citation
Noorit P, Siribumrungwong B, Thakkinstian A. Clinical prediction score for superficial surgical site infection after appendectomy in adults with complicated appendicitis. World J Emerg Surg. 2018 Jun 18;13:23. doi: 10.1186/s13017-018-0186-1. eCollection 2018.
Results Reference
derived
Learn more about this trial
Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis
We'll reach out to this number within 24 hrs